Scientific considerations for global drug development.
Jennifer L WilsonKit Wun Kathy CheungLawrence LinElizabeth A E GreenAnalia I PorrásLing ZouDavid MukangaPaul A AkpaDelese Mimi DarkoRae YuanSheng DingWiltshire C N JohnsonHoward A LeeEmer CookeCarl C PeckSteven E KernDan HartmanYoshikazu HayashiPeter W MarksRuss B AltmanMurray M LumpkinKathleen M GiacominiTerrence F BlaschkePublished in: Science translational medicine (2021)
Requiring regional or in-country confirmatory clinical trials before approval of drugs already approved elsewhere delays access to medicines in low- and middle-income countries and raises drug costs. Here, we discuss the scientific and technological advances that may reduce the need for in-country or in-region clinical trials for drugs approved in other countries and limitations of these advances that could necessitate in-region clinical studies.